ABSTRACT The primary purpose of Clinical Protocol and Data Management (CPDM) is to facilitate, support and assure the generation and conduct of high impact patient research in the most efficient and safe way possible to substantially reduce the burden of cancer for the people of Hawaii. CPDM provides the infrastructure to give Hawaii?s community-based providers and the patients they serve access to state-of-the-science clinical trials. Clinical protocol and data management provides central management and oversight functions for coordinating, facilitating, and reporting on the cancer clinical trials. These include trials from the NCI Research Base and Cooperative Groups, industry-sponsored trials and investigator-initiated trials (IITs). It has a complementary function to the Protocol Review and Monitoring System. The principal components of Clinical Protocol and Data Management are the Clinical Trials Office (CTO), including regulatory affairs and protocol IT management through OnCore, staff training activities, and investigator education and training activities. Data and Safety Monitoring (DSM) functions includes the DSMC (Data Safety and Monitoring Committee) which is responsible for review of data and safety monitoring plans for all protocols, review and monitoring of all aspects of trials related to patient safety and adverse events and oversight of IIT conduct. A second component of DSM is Quality Assurance and Audit functions, directed by the UHCC Office of Compliance that serves as the responsible entity for quality assurance for all clinical research activities across the entire UHCC- supported network. This office conducts internal audits and monitors reports of external audits from NCI Research Base and Cooperative Groups and industry sponsors. Inclusion of women, minorities and children onto clinical trials is a major emphasis for UHCC with a particular focus on populations with significant cancer health disparities such as Native Hawaiians. Nearly 80% of all accrual to therapeutic trials is represented by non-white minority groups, including 17% Native Hawaiian. Other (non-therapeutic) interventional trials include prevention and screening studies specifically targeted toward Native Hawaiian and other Pacific Islander populations and have an even higher rate of minority enrollment. Pediatric cancer enrollment includes 42% Native Hawaiian and 18% Filipino, both groups that have significant disparities related to cancer mortality rates among the diverse racial and ethnic milieu in Hawai?i.